Will neuregulin help with heart failure?
The new drug has demonstrated effectiveness in heart failure
Anna Stavina, XX2 century
Cimaglermin, a new experimental drug also known as "glial growth factor 2" (GGF2) and "neuregulin-1ß" (neuregulin-1ß), can help in restoring heart function in patients suffering from heart failure. The results of the first human trials of the drug were published in JACC: Basic to Translational Science (Lenihan et al., A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1ß3) in Patients With Systolic Dysfunction and Heart Failure).
Heart failure, characterized by deterioration of cardiac activity, is one of the most common causes of death worldwide. Many patients suffering from this disease, especially those diagnosed with severe left ventricular systolic dysfunction, do not respond sufficiently to existing therapy options.
The researchers studied the safety and efficacy of a single administration of cimaglermin. The drug is a growth factor that helps the structural, metabolic and contractile elements of the heart to recover after damage. The study included 40 patients with heart failure who received the most appropriate therapy for at least three months before starting work. In patients who received a high dose of cimaglermin, a stable increase in the left ventricular ejection fraction (LVEF) was recorded for 90 days. The maximum effect was registered on the 28th day after administration of the drug. The change in LVL was compared with the data obtained in the control group of patients who received a placebo.
Previously, the drug has demonstrated positive effects on animal models of heart attacks and strokes. In particular, accelerated axon germination and synapse formation were observed in rats who had suffered a stroke against the background of the use of cimaglermin.
"The results of the work support the continuation of clinical trials of the drug "cimaglermin", including the study of the safety of the drug and a detailed study of its effect on the clinical outcomes of heart failure, – says the lead author of the study, Dr. Daniel Lenihan (Daniel Lenihan) from the Department of cardiovascular Drugs at Vanderbilt University (Vanderbilt University). – As is the case with any other experimental drugs, to determine the ratio of the risks associated with cimaglermin and the benefits of its use, additional research and regulatory control will be required. Only after that it will be possible to understand whether this drug should be approved for clinical use."
The most common side effects associated with taking the drug were headache and nausea. One patient who received the maximum of the planned dose of cimaglermin had adverse events that fell under the criteria of the Food and Drug Administration (Food and Drug Administration). In accordance with the recommendations, the participant was withdrawn from the study due to liver damage caused by the drug.
The limitations of the study included a small sample size and a single, rather than a course, intake of the drug.
"Although the results of this work should be considered preliminary due to the small number of participants, they are very impressive," said Dr. Douglas Mann, editor-in–chief of the journal JACC: Basic to Translational Science. "Instead of blocking the fundamental mechanisms leading to heart failure, we can, as early results of the use of cimaglermin show, to develop a drug that helps the heart to recover at the expense of its own resources. If the results of this work can be replicated in phase II and III clinical trials, this may lead to a paradigm shift in the treatment of patients with heart failure."
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27.12.2016